With over 40 years’ experience in the field of phytotherapy medications and dietary supplements, Arkopharma Laboratories’ aspirations and commitment have been translated into compliance with a range of procedural standards and certifications.
ISO 22000 STANDARD
For dietary supplements and nutritional products
Arkopharma Laboratories is ISO 22000 certified for the design, development, manufacture, storage and distribution of its nutritional products and dietary supplements.
This internationally recognized standard guarantees that the dietary supplements and nutritional products distributed by Arkopharma Laboratories meet all the requirements in terms of food safety and quality. Arkopharma is the first laboratory to obtain ISO 22000 certification.
GOOD MANUFACTURING PRACTICES (GMP)
As a pharmaceutical laboratory, Arkopharma Laboratories is regularly inspected by the ANSM (French National Agency for Medicines and Health Products Safety), which awards a certificate attesting compliance with Good Manufacturing Practices (GMP).
Good manufacturing practices mean that medications are guaranteed to be manufactured and checked according to the quality standards applicable to their use. They apply to both production and quality control.
EUROPEAN REGULATIONS RELATED TO ORGANIC PRODUCTION METHODS
For dietary supplements and products certified as organic
Organic farming has numerous benefits for society, both as regards the preservation of land, air and water quality, and the biodiversity of nature, as well as the availability of products with unquestionable qualities in terms of health and nutrition, with a clearly identified origin and quality level.
To this end, Arkopharma Laboratories is regularly audited by a certifying organization (ECOCERT) to check that it complies with stringent Organic Farming requirements. Arkopharma Laboratories committed itself to applying these sustainable development methods as early as 1993.
ISO 13485 STANDARD
For medical devices
Arkopharma Laboratories is ISO 13485 certified for the design, development, manufacture, storage and distribution of its medical devices. This standard incorporates specific requirements such as risk analysis of the production processes used for these medical devices.
Medical Devices are subject to a classification system (I, IIa, IIb and III), defined according to the site and duration of action and the level of potential hazard inherent in the product. In order to receive the green light for market launch, the devices must be CE marked, testifying that they meet the regulatory requirements.